Novel Pharmaceutical Composition and Its Use in a Method For Treatment of Patients With Upper Respiratory Mucosal Congestion
a technology of upper respiratory mucosal congestion and composition, which is applied in the field of new pharmaceutical composition, can solve the problems of reducing the effect of end-of-dose dose, adverse effects, and higher incidence of adverse drug reactions of cetirizin
Inactive Publication Date: 2009-08-27
AFT PHARM LTD
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- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Benefits of technology
The patent describes a method of treating upper respiratory mucosal congestion by giving a patient a pharmaceutical composition containing a combination of loratadine and phenylephrine. The composition is preferably a pill, capsule, or tablet that is taken four times a day. The treatment can help to reduce symptoms such as nasal congestion, headaches, and sneezing. The composition may also contain other ingredients such as hydroxy-α-[(methylamino) methyl] benzenemethanol or a suitable salt thereof, and may be formulated as a syrup or a solution.
Problems solved by technology
However, in comparison to loratadine, cetirizine has been reported to have a higher incidence of adverse drug reactions (ADRs), especially central nervous system ADRs1.
However, there are adverse effects that can occur at peak concentration and also with end-of-dose diminution of effect.
However, products containing pseudoephedrine are now subject to abuse problems associated with illicit drug use in the community.
This has resulted in pharmacy hold-ups, stolen stock from warehouses and significant related crime.
The resulting crime, and its effects on the outlets which supply these medications to the market, means that some outlets are choosing not to stock these products, or at least restrict their availability.
This makes them less accessible to those with a genuine need for the medications.
Method used
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example
[0060]The components shown in Table 3 are combined into a single tablet and taken by either adults or children aged 12 years or older. The tablet may be taken up to 4 times a day giving a maximum dose of 10 mg of loratadine and 40 mg of phenylephrine per day.
TABLE 3Combination Composition FormulationReferenceQty. perto specifi-Name of ingredienttabletFunctioncationsActive ingredient:Phenylephrine10.00mgActive ingredientPh. Eur.HydrochlorideLoratadine2.50mgActive ingredientIHSOther ingredients:Lactose180.40mgDiluentPh. Eur.Maize starch140.00mgDiluent, BinderPh. Eur.Pregelatinised starch10.365mgBinderPh. Eur.Lake of quinoline yellow0.20mgColourantIHSSodium metabisulphite0.40mgAntioxidantPh. Eur.Disodium EDTA0.14mgChelating AgentPh. Eur.Talc3.00mgGlidantPh. Eur.Magnesium stearate3.00mgLubricantPh. Eur.
[0061]The formulation administered 4 times daily provides effective 24 hour treatment of the symptoms of upper respiratory mucosal congestion with reduced adverse effects and without usin...
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Abstract
The present invention relates to a pharmaceutical composition including loratidine, its use in the treatment of upper respiratory mucosal congestion and a method of administration of the composition. Particularly, though not exclusively, the invention relates to a pharmaceutical composition including loratidine in an amount suitable for administration a maximum of 4 times a day, and a second active that is a hydroxyl-α-[(methylamino) methyl]-benzenemethanol, such 3-hydroxyl-α-[(methylamino) methyl]-benzenemethanol (phenylephrine), or salt thereof.
Description
INTRODUCTION[0001]The present invention relates to a pharmaceutical composition including loratidine, its use in the treatment of upper respiratory mucosal congestion and a method of administration of the composition. Particularly, though not exclusively, the invention relates to a pharmaceutical composition including loratidine in an amount suitable for administration a maximum of 4 times a day, and a second active that is a hydroxyl-α-[(methylamino) methyl]-benzenemethanol, such 3-hydroxyl-α-[(methylamino) methyl]-benzenemethanol (phenylephrine), or salt thereof.BACKGROUND[0002]Upper respiratory mucosal congestion caused by infections such as the common cold and influenza, or allergic rhinitis, can lead to a number of nasal and ocular symptoms. These include rhinitis and sinusitis, nasal and sinus congestion or excessive secretions, headaches, sneezing and itching and excessive lacrimation. Infections such as the common cold can be very common over the winter months, while the sym...
Claims
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IPC IPC(8): A61K31/4545A61P11/02
CPCA61K31/137A61K31/4545A61K2300/00A61P11/02
InventorATKINSON, HARTLEY
OwnerAFT PHARM LTD